51O(K) SUMMARY: V.A.C@ Therapy family of devices. I. Name of Device: V.A.C.@ ATSTM, mini V.A.C.@, V.A.C. 8 FreedomTM 11. Classification Name: Powered Suction Pump 21 CFR 878.4780 III.510(k) Applicant: Kinetic Concepts, Inc. (KCI) 8023 Vantage Drive San Antonio, TX 78265-8508 Contact: Judith Harbour 1-800-275-4524 IV. Substantial Equivalence: V. Description of Device - V.A.C. Plus 510(k) No.K992448 Ambulatory V.A.C. 510(k) No.K971548 All models of the VAC family of devices, including the V.A.C.43 ATSTM, mini V.A.C.0, and the V.A.C.@ FreedomTM, consist of a vacuum control unit with an integrated collection canister and power supply. VI. Intended Use of the Device The V.A.C,@ family of devices are feedback-controlled negative pressure devices used to help promote wound healing, through means including vacuum assisted drainage and removal of infectious material or other fluids, under the influence of continuous andor intermittent suction pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site. VII.Summary of the technological characteristics of the device compared to the predicate device. Each of the devices in the V.A.C. family of devices consists of the same basic technology, and do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness. Each device consists of a vacuum control unit with an integrated collection canister and power supply (battery or AC). The primary differences in these models relate to size and weight. All models of the V.A.C. fainily of devices are designed to help promote wound healing, through the application of controlled negative pressure to the surface and margins of the wound. This negative pressure therapy is applied to the V.A.C. foam dressing positioned in the wound cavity or over a flap or graft. This pressure distributing foam dressing helps remove fluids from the wound. The devices are designed to treat wounds such as chronic, acute, traumatic, subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure); flaps; and grafts.
V.A.C. Family ofdevices Page 2 VIII. Testing Verification and validation testing of the V.A.C. family of devices, including functional performance testing and electrical leakage testing, was conducted in accordance with established design control procedures. IX. Conclusions Based upon 'the testing and comparison to the predicate devices, the V.A.C. family of devices has the same intended uses, with similar technological characteristics. The system performs as intended and raises no new safety or effectiveness issues.
DEPARTMENT OF HEALTH &. HUMAN SERVICES Public Health Service APR -72009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230 Re: K032310 TradelDevice Name: The V.A.C. family ofdevices: mini V.A.c., V.A.C. Freedom, V.A.C. ATSTM Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: July 21, 2003 Received: August 4, 2003 Dear Ms. Oviatt: This letter corrects our substantially equivalent letter of October 10, 2003. We have reviewed your Section SIO(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date ofthe Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval ofa premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions ofthe Act. The general controls provisions ofthe Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Ifyour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance ofa substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements ofthe Act or any Federal statutes and regulations administered by other
Page 2 - Ms. Christy Oviatt Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 ofthe Act); 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence ofyour device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. Ifyou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office ofsurveillance and Biometric's (OSB's) Division ofpostmarket Surveillance at (240) 276 3474. For questions regarding the reporting ofdevice adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, fi,e /d-,;?~ Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office ofdevice Evaluation Center for Devices and Radiological Health Enclosure
Statement of Indications for Use Page 1 of 1 510(k) Number (if known): MJ:A.~I' Device Name: The V.A.C. family of devices: mini v.a.c., V.A.C. Freedom, V.A.C. ATSTM Indications For Use: The V.A.C. family of devices with woundslte feedback control are negative pressure devices used to help promote wound healing. through means including drainage and removal of infectious material or other fluids. under the Influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE). X Prescription Use: OR Over the Counter Use: (per 21 CFR 801.109) ~ e. ~OPtional Format 1-2-96) (Division Sign-Oft) Division ofgeneral, Restorative and Neurological Devices 510(k) Number KIJ2 3231 ()